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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 65-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
M21-0746147-9/5/1 09-Jul-2012 65FCK04 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
112-8368095-2/7/1/C 31-Jul-2012 65LAJ99 3006222866 Rdl Cosmetics Laboratory Inc Philippines
 
EH3-1271818-0/1/2 24-Jul-2012 65LBJ11 3004989717 Able C & C Co., Ltd. Korea, Republic Of (South)
 
EH3-1271818-0/4/2 24-Jul-2012 65LBJ11 3004989717 Able C & C Co., Ltd. Korea, Republic Of (South)
 
EH3-1271818-0/5/19 31-Jul-2012 65LBJ11 3004989717 Able C & C Co., Ltd. Korea, Republic Of (South)
 
EH3-1271818-0/17/9 31-Jul-2012 65LBJ11 3004989717 Able C & C Co., Ltd. Korea, Republic Of (South)
 
AEK-0193937-6/1/1 20-Jul-2012 65PIY02 3009183838 Amtec Healthcare Pvt Ltd India
 
UPS-6468888-6/3/1/C 03-Jul-2012 65QAY99 3005778261 Astellas Pharma Europe Bv Netherlands
 
AEK-0219131-6/1/1 23-Jul-2012 65RAJ29 3009312458 Demega Formulations India
 
KM6-0057975-9/6/1 13-Jul-2012 65RBZ18 3008301002 Veerprabhu Export House India
 
KM6-0057866-0/1/1 25-Jul-2012 65RBZ18 3008301002 Veerprabhu Export House India
 
231-2489832-5/19/2 30-Jul-2012 65RBZ18 3009603460 Dr. Oetker, Spol. Sro Czech Republic
 
KM6-0057264-8/18/1 31-Jul-2012 65RBZ18 3004270701 RAMDEV FOOD PRODUCTS PVT. LTD. India
 
KM6-0057264-8/18/2 31-Jul-2012 65RBZ18 3004270701 RAMDEV FOOD PRODUCTS PVT. LTD. India
 
AEK-0227168-8/1/1 23-Jul-2012 65RCJ29 3009312458 Demega Formulations India
 
112-8450224-7/1/1 31-Jul-2012 65RCX04 3006671686 Global Calcium Pvt Ltd India
 
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